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Development and validation of a stability-indicating lc method for the determination of tenofovir disoproxil fumarate in pharmaceutical formulation

Author(s): Shweta Havele | Sunil R. Dhaneshwar

Journal: Songklanakarin Journal of Science and Technology
ISSN 0125-3395

Volume: 34;
Issue: 6;
Start page: 615;
Date: 2012;
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Keywords: HPLC | forced degradation | validation | stress study | tenoforvir disoproxil fumarate

The present study describes the degradation of tenoforvir disoproxil fumarate (teno) under different prescribed stressconditions (hydrolysis, oxidation, dry and wet heat and photolysis) following the International Conference on Harmonization and application of a specific and selective stability-indicating reversed-phase high–performance liquid chromatography(HPLC) assay. Separation of drug and degradation products was successfully achieved on C18 analytical column usingmethanol: water (60:40, v/v) at a flow rate of 1.0 ml/min and detection at 260 nm, the mass balance was found to be close to100.4%. The developed HPLC method was validated with respect to linearity, accuracy, precision, robustness, and accuracy.
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